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ONO-7913 Phase I Study (ONO-7913)

  • identifier


  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 27, 2020

  • Last update posted

    May 10, 2021

Study Description

Brief summary:

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

  • Condition or Disease:Solid Tumor
  • Intervention/Treatment: Biological: ONO-7913
  • Phase: Phase 1

Detailed Description


Study Design

  • Study Type: Interventional
  • Actual Enrollment: 7 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: May 2023
  • Estimated Study Completion Date: May 2023

Arms and interventions

Arm Intervention/treatment
Experimental: ONO-7913 as a Single Agent
Biological: ONO-7913
ONO-7913 will be administered by intravenous continuous infusion during the designated time.

Outcome Measures

  • Primary Outcome Measures: 1. Dose-limiting toxicities [ Time Frame: 28 days ]
    Number of participants with a DLT
  • 2. Adverse events [ Time Frame: Up to 24 months ]
    Assessed by the NCI CTCAE v5.0 criteria
  • Secondary Outcome Measures: 1. Concentration vs time of ONO-7913 as single dose [ Time Frame: Up to 24 months ]
    PK profile

Eligibility Criteria

  • Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria: 1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status of 0-1 3. Patients with life expectancy of at least 3 months Exclusion Criteria: 1. Patients with multiple cancers 2. Patients with history of serious allergy

Contacts and Locations



Japan, Tokyo
Local Institution

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd


Study Chair: Kazuhiro Nakabayashi Ono Pharmaceutical Co. Ltd

More Information

  • Responsible Party: Ono Pharmaceutical Co. Ltd
  • Identifier: NCT04403308 History of Changes
  • Other Study ID Numbers: ONO-7913-01
  • First Posted: May 27, 2020 Key Record Dates
  • Last Update Posted: May 10, 2021
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing

  • Plan to Share IPD: Yes
  • URL:
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No